Fluid delivery system having a plurality of resilient pressurizing chambers

ABSTRACT

A fluid delivery system includes a fluid container, two or more pressurizing chambers in fluid connection with the fluid container, a drive mechanism in operative connection with the two or more pressurizing chambers to pump fluid from the fluid container and an outlet in fluid connection with the two or more pressurizing chambers. Each of the two or more pressurizing chambers is formed from a flexible, resilient material that is adapted to be compressed to pressurize fluid therewithin.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.11/072,999, filed on Apr. 4, 2005, the contents of which areincorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention relates generally to fluid delivery systems, tofluid delivery devices and to methods of fluid delivery, and,especially, to fluid delivery systems, devices and method for deliveryof medical fluids to a patient.

In many medical procedures, such as drug delivery, it is desirable toinject a fluid into a patient. Likewise, numerous types of contrastmedia (often referred to simply as contrast) are injected into a patientfor many diagnostic and therapeutic imaging procedures. For example,contrast media are used in diagnostic procedures such as X-rayprocedures (including, for example, angiography, venography andurography), computed tomography (CT) scanning, magnetic resonanceimaging (MRI), and ultrasonic imaging. Contrast media are also usedduring therapeutic procedures, including, for example, angioplasty andother interventional radiological procedures as well as chemotherapy.Saline is often used as a diluent or flushing fluid in conjunction withcontrast media. Regardless of the type of procedure, any fluid injectedinto the patient must be sterile and contain a minimum of pyrogens.Moreover, injection of air should be minimized or completely eliminated.

Under the typical current practice of injecting contrast media viasyringe pumping systems using loadable, empty syringes, hospitals mustpurchase and stock many contrast media concentrations in multiplecontainer sizes in an attempt to provide the correct concentration andamount of a specific contrast for a specific procedure, while minimizingthe wastage of contrast. In that regard, contrast is typically veryexpensive. Most contrast media are thus provided by manufacturers innumerous concentrations in sterilized containers (such as glass bottlesor plastic packages) ranging, for example, incrementally in size from 20ml to 500 ml (and even up to 1000 ml under current European practice).These containers are generally designed for a single use (that is, oncea container is opened for a patient, it is used for that patient only).The contrast is generally aspirated from such containers via the syringepump used to inject the contrast, and any contrast remaining in thecontainer is discarded to prevent infection with potentiallycontaminated contrast. The hospital staff is faced with the task ofchoosing an appropriately sized contrast container to assure an optimumstudy while minimizing discarded contrast. Time consuming procedures arerequired to reload the syringe if more contrast is required thanoriginally calculated. On the other hand, expensive waste results ifonly a portion of a filled syringe is injected. The inventory ofcontrast containers required under the current system increases costsand regulatory burdens throughout the contrast media supplier-consumerchain.

Alternatively, contrast is provided in prefilled syringes which can beloaded onto an injector without time-consuming filling procedures.However, such syringes are provided in single-dose volumes. The hospitalmust still maintain an inventory of disposable syringes of differentvolumes and concentration. Moreover, hospital staff is still required tochoose a prefilled syringe of appropriate volume to ensure thatsufficient contrast is available during the injection procedure. Wasteoccurs if the prefilled syringe includes excess fluid. Waste alsooccurs, for example, in the case that a prefilled syringe includesinsufficient fluid, resulting in termination of a procedure or use ofonly a portion of a second prefilled syringe.

Many of the costs, regulatory burdens and other problems associated withthe use of multiple contrast containers, and even prefilled syringes,can be substantially eliminated through use of relatively large contrastmedia containers for single- and multiple-patient use in connection witha pumping system allowing any volume and concentration (as limited bythe volume and concentration of the medial container) of contrast to beinjected as determined by the hospital staff before or during aprocedure. Relatively large containers of a fluid such as saline can beused for flushing and/or dilution. U.S. Pat. Nos. 5,916,197 and6,197,000, assigned to the assignee of the present invention, thedisclosures of which are incorporated herein by reference, disclosepumping systems that are removably connectable to a relatively largesource of contrast or saline. Those pumping systems are adapted toprovide controlled, continuous flow of generally any volume of fluidduring an injection procedure.

Although continuous pumping systems such as disclosed in U.S. Pat. Nos.5,916,197 and 6,197,000 can eliminate many of the problems associatedwith current injection practices, a number of problems persist. Forexample, there is a risk of contamination by operating personnel whenremovable fluid connections are made or broken (such as the fluidconnection between a fluid source and the pumping mechanism of thepumping system). Making such fluid connections also requires use ofvaluable and limited operator time. Furthermore, required operator tasksintroduce the potential for human error.

It thus remains desirable to develop improved fluid delivery systems,fluid delivery devices and methods of fluid delivery.

SUMMARY OF THE INVENTION

In one aspect, the present invention provides a fluid delivery systemincluding at least one container for fluid to be delivered to a patient,a continuous pumping mechanism in non-removable fluid connection withthe container, and an outlet in fluid connection with the pumpingmechanism. The container can be a flexible container (for example, aflexible plastic bag) or a rigid container (for example, a glasscontainer).

In general, the continuous pumping mechanisms of the present inventionenable convenient operation via continuous (or uninterrupted) pumping offluid from the container (without, for example, having to stop andreload) over multiple procedures and/or patients. Moreover, a patientdose can be determined in real time as the procedure is progressing,ensuring that the patient will be neither over dosed nor under dosed.Moreover, no waste of fluids occurs as a result of over dosing or underdosing.

In general, the continuous pumping mechanisms suitable for use in thepresent invention are energy assisted devices (for example, electricalenergy, mechanical energy, manual energy, pneumatic energy etc.) asopposed to, for example, gravity fed or drip devices. Examples ofcontinuous pumps suitable for use in the present invention include, butare not limited to, rotary pumps, multi-chambered piston pumps and gearpumps. In certain embodiments, positive displacement pumps arepreferred. In positive displacement of the liquid medium, there isgenerally a one-to-one correspondence between the length of a stroke(typically, a generally linear stroke) of a pressurizing mechanism andthe amount of liquid medium displaced. Positive displacement throughgenerally linear motion can, for example, provide better volumetricefficiency than achievable through the use of rotational or rotarypumps. Volumetric efficiency can be defined as the volume of fluidactually per unit mechanical displacement divided by the theoreticalvolume of fluid delivered per unit mechanical displacement. Thevolumetric efficiency of rotational pumps can be dependent upon thepressure and flow rate of the liquid medium. In certain embodiments,multi-chambered, positive displacement pumps are preferred.

Continuous pumping mechanisms for use in the present invention arepreferably capable of achieving relatively high flow rates (for example,flow rates in excess of 0.1 ml/second and often in the range ofapproximately 0.1 ml/second to 50 ml/second) and/or high pressure (forexample, in excess of 20 psi) injections without excessive pulsatileflow. Typically, high flow rates are associated with high pressures as aresult of delivery of such high flow rates through relatively small-boreflow path elements (for example, catheters).

Preferably, continuous pumping mechanisms for use in the presentinvention provide for relatively accurate control of a bolus of fluiddelivered to a patient (for example, rise and fall times of under 100 mscan be provided in the case of, for example, a square bolus). A squarebolus of fluid delivery or other bolus configuration may be required foroptimum enhancement.

The continuous pumping mechanisms of the present invention facilitateclosed feedback control during fluid delivery. For example, based on themeasured results of the fluid already delivered, fluid deliveryparameters (for example, flow rate, volume, concentration etc.) can bereadily adjusted in real time based on the measure real time results.The continuous pumping mechanisms of the present invention can alsopreferably provide for relatively accurate control of the delivery offluids. (for example, within ±2% of volume and flow rate, and within ±50psi of pressure controlled) over a broad range of flow rates.

The fluid delivery system of the present invention can further includeat least one one-way valve or other mechanism in fluid connection withthe container (for example, between the pumping mechanism and thecontainer) to prevent flow of fluids from outside the container into thecontainer (for example, from the pumping mechanism into the container).In one embodiment, the container includes a plurality of ports in fluidconnection with the pumping mechanism, and a one way valve is in fluidconnection between the pumping mechanism and each the plurality ofports, to prevent flow from the pumping mechanism to the container.Preventing flow of fluid from outside of the container into thecontainer (for example, from the pumping mechanism to the container) canreduce the likelihood of cross-contamination between patients when thefluid delivery systems of the present invention are used in connectionwith multiple patients. Likewise, undesirable fluids (for example, airor, indeed, any fluid other than the original contents of the containercan be prevented from entering the container. Additionally oralternatively, the pumping mechanism is adapted (for example, via meansknown in the pumping arts) so that it cannot pump fluid from outside thecontainer into the container. In other words, the pumping mechanismcannot be operated in reverse. Preventing such reverse flow can furtherreduce or eliminate the likelihood of cross-contamination betweenpatients and reduce the likelihood of drawing fluids (for example, air)into the container. Preferably, continuous pumping mechanisms used inthe present invention facilitate generally the prevention of or theminimization of delivery of air to a patient during an injectionprocedure.

In one embodiment, the pumping mechanism includes at least onepressurizing chamber in fluid connection with the container. Thepressurizing chamber is adapted to be placed in operative, removableconnection with an energy assisted drive mechanism to pump fluid fromwithin the container. As described above, fluid from the container can,for example, be pressurized within the pressurizing chamber via positivedisplacement. The pumping mechanism can include a plurality ofpressurizing chambers in which fluid from the container is pressurizedfor delivery to the patient via positive displacement. In oneembodiment, each of the pressurizing chambers is in fluid connectionwith a single pumping mechanism outlet.

The pressurizing chambers can, for example, be formed from a flexible,resilient material that can be compressed to pressurize fluid within thepressurizing chamber. The flexible material of the pressurizing chamberscan be suitably resilient such that recovery of the flexible material ofthe pressurizing chambers creates a pressure difference between thepressurizing chamber and the storage container suitable to draw fluidfrom the storage container into the pressurizing chambers.

In another embodiment, each of the pressurizing chambers comprises apiston slidably disposed therein.

The container of the present invention can, for example, filled withfluid to be injected and be substantially devoid of air (for example,when shipped to the end user). For example, the volume of air in thecontainer can be less than 1 volume percent. Additionally oralternatively, the end user can simply purge air from the container asknown in the medical injection arts.

In one embodiment, the container comprises no inlet port through which afluid can enter the container. In this manner, contamination of fluidwithin the container with external agents can more easily be prevented.However, such inlet ports can be provided in certain embodiments. Thefluid container and the pumping mechanism of the fluid delivery systemsof the present invention can, for example, be disposable as unit.

The outlet of the pumping mechanism can, for example, be placed in fluidconnection with a connector adapted to place the fluid delivery systemin fluid connection with a per-patient disposable tubing set. Theconnector can, for example, be adapted to place the pumping mechanism influid connection with a plurality of per-patient disposable tubing setssequentially to allow injection of fluid from the container intomultiple patients. The connector can, for example, be swabable to cleanthe connector after a tubing set has been removed therefore and prior toconnection of another tubing set thereto.

In another aspect, the present invention provides a fluid deliverysystem, including: at least one container for fluid to be delivered to apatient, a drive mechanism, and a continuous pumping mechanism innon-removable fluid connection with the fluid container. The pumpingmechanism is adapted to be placed in removable, operative connectionwith the drive mechanism. The fluid delivery system further comprises anoutlet in fluid connection with the pumping mechanism.

As described above, the fluid delivery system can further include atleast one one-way valve in fluid connection between the pumpingmechanism and the container to prevent flow from the pumping mechanismto the container. In one embodiment, the pumping mechanism includes aplurality of pressurizing chambers in which fluid from the container ispressurized at least one one-way valve in fluid connection between thepumping mechanism and the container to prevent flow from the pumpingmechanism to the container. Likewise, the pumping mechanism can beadapted to not pump fluid from outside the container into the container.

Each of the pressurizing chambers can be in fluid connection with asingle pumping mechanism outlet. In one embodiment, the pressurizingchambers are formed from a flexible, resilient material that can becompressed to pressurize fluid within the pressurizing chamber. Theflexible material of the pressurizing chambers can be suitably resilientsuch that recovery of the flexible material of the pressurizing chamberscreates a pressure difference between the pressurizing chamber and thestorage container suitable to draw fluid from the storage container intothe pressurizing chambers. The drive mechanism can include at least onedrive member to compress the pressurizing chambers. The drive mechanismcan, for example, include a drive member for each of the pressurizingchambers to compress each of the pressurizing chambers in a timedfashion. The operation of the drive member can be appropriately timed toreduce pulsatile nature of the flow.

In another embodiment, each of the pressurizing chambers includes apiston slidably disposed therein. In this embodiment, the pumpingmechanism can, for example, include a plurality of connectors whereinone of the plurality of connectors is in operative connection with eachof the pistons. Each of the plurality of connectors is adapted to beplaced in releasable connection with the drive mechanism. The drivemechanism can, for example, include a plurality of drive members. Eachof the plurality of drive member can include a cooperating connectoradapted to be placed in removable, operative connection with one of theconnectors of the pumping mechanism.

In another aspect, the present invention provides a method ofdistributing a fluid to be injected into a patient, including the stepof creating a fluid delivery system by filling at least one containerwith fluid to be to be injected into at least one patient. The fluidcontainer is placed in non-removable fluid connection with a continuouspumping mechanism (as described above). The pumping mechanism includesan outlet. The method further includes transporting the fluid deliverysystem to a user.

The pumping mechanism can be in non-removable fluid connection withcontainer prior to filling the container. The pumping mechanism can alsoplaced in non-removable fluid connection with container after fillingthe container.

The method can further include the step of priming the pumping mechanismwith fluid from the container prior to transporting the fluid deliverysystem. The method can also include the step of purging air from atleast the container of the fluid delivery system prior to transportingthe fluid delivery system.

The method can further include the step of placing the fluid deliverysystem in a package prior to transporting the fluid delivery system. Thefluid delivery system can be packaged in a sterile state.

In another aspect, the present invention provides a method of deliveryfluid to a patient, including the step of removing a fluid deliverysystem from a package. The fluid delivery system includes: at least onecontainer having therein fluid to be delivered to a patient, acontinuous pumping mechanism in non-removable fluid connection with thecontainer, and an outlet in fluid connection with the pumping mechanism.The method further includes the steps of removably connecting thepumping mechanism to a drive mechanism and connecting a first patientinterface to the outlet.

The method can further include injecting fluid into at least a firstpatient. The method can also include the step of removing the firstpatient interface from connection with the outlet after injecting fluidinto the first patient and connecting a second patient interface to theoutlet. The method can further include the step of disposing of thefluid delivery system after injecting fluid therefrom.

In a further aspect, the present invention provides a kit for fluiddelivery packaged in a sterile container. The kit includes at least onefluid delivery system including: at least one container for fluid to bedelivered to a patient, a continuous pumping mechanism in non-removablefluid connection with the container, and an outlet in fluid connectionwith the pumping mechanism. The kit can further include at least oneper-patient disposable tubing set including a connector to connect tothe outlet of the fluid delivery system. A plurality of per-patientdisposable tubing sets can be provided. The kit can also include atleast one manual syringe connectable to the tubing set. The manualsyringe can, for example, be adapted to draw blood from a patient or toinject a fluid.

A plurality of fluid delivery systems, wherein each of the fluiddelivery systems includes a different fluid in the container thereof,can be included in the system. In one embodiment, the container of oneof the fluid delivery systems encloses a contrast enhancement medium andthe container of another one of the fluid delivery systems enclosessaline.

In an additional aspect, the present invention provides a fluid deliverydevice, including: at least one inlet connectable to a fluid supply andat least two resilient pressurizing chambers in fluid connection withthe at least one inlet. Each of the pressurizing chambers is formed froma flexible material that can be compressed to pressurize fluid withinthe pressurizing chamber. The fluid delivery system further includes aninlet valve in fluid connection with each of the pressurizing chambersbetween the storage container and the pressurizing chamber. The inletvalve is operable to allow fluid to enter the pressurizing chamber fromthe storage container but to prevent fluid from flowing from thepressurizing chamber into the storage container. A common outlet is influid connection with the pressurizing chambers. An outlet valve is influid connection with each of the pressurizing chambers between thepressurizing chamber and the outlet. The outlet valve is operable toallow fluid to enter the outlet from the pressurizing chamber but toprevent fluid from flowing from the outlet into the pressurizingchamber.

In another aspect, the present invention provides a fluid deliverysystem including: at least one container for fluid to be delivered to apatient and a pumping mechanism in non-removable fluid connection withthe container. The pumping mechanism is suitable to pressurize the fluidto at least 20 psi. The fluid delivery system further includes an outletin fluid connection with the pumping mechanism. In one embodiment, thepumping mechanism is suitable to pressurize the fluid to at least 50psi. In another embodiment, the pumping mechanism is suitable topressurize the fluid to at least 100 psi. In still another embodiment,the pumping mechanism is suitable to pressurize the fluid to at least300 psi.

In a further aspect, the present invention provides a fluid deliverysystem including: at least one container for fluid to be delivered to apatient; a pumping mechanism in non-removable fluid connection with thecontainer. The pumping mechanism is suitable to pressurize the fluidwith a degree of pulsatile flow no greater than 25%, wherein the degreeof pulsatile flow is defined by the following equation:100%*(max flow−min flow)/average flow.The fluid delivery system further includes an outlet in fluid connectionwith the pumping mechanism. In one embodiment, the degree of pulsatileflow is no greater than 20%. In another embodiment, the degree ofpulsatile flow is no greater than 15%. In still another embodiment, thedegree of pulsatile flow is no greater than 10%.

In another aspect, the present invention provides a fluid deliverysystem including: at least one container for fluid to be delivered to apatient. The container has a single port. The fluid delivery systemfurther includes a pumping mechanism in non-removable fluid connectionwith the single port of the container and a mechanism adapted to preventreverse flow through the pump and into the container via the singleport.

In another aspect, the present invention provides a fluid deliverysystem including: at least one container for fluid to be delivered to apatient; a pumping mechanism in non-removable fluid connection with thecontainer, and an outlet in fluid connection with the pumping mechanism.The container can, for example, include less than 1% by volume of air.In one embodiment, the container has less than 3 ml of air therein.

BRIEF DESCRIPTION OF THE DRAWINGS

Other aspects of the invention and their advantages will be discernedfrom the following detailed description when read in connection with theaccompanying drawings, in which:

FIG. 1A illustrates an embodiment of a fluid delivery system of thepresent invention and an embodiment of a drive mechanism for use withthe pumping mechanism of the fluid delivery system of FIG. 1A.

FIG. 1B illustrates the fluid delivery system of FIG. 1A in position tobe in operative connection with the drive mechanism.

FIG. 1C illustrates the fluid delivery system of FIG. 1A in operativeconnection with the drive mechanism.

FIG. 1D illustrates an enlarged view of one of the drive members of thedrive mechanism of FIG. 1A compressing a pressurizing chamber of thepumping mechanism of the fluid delivery system of FIG. 1A.

FIG. 1E illustrates an alternative embodiment of a pumping mechanism ofthe present invention which operates in a manner similar to the pumpingmechanism of FIG. 1A but includes a single inlet in fluid connectionwith the fluid container.

FIG. 2A illustrates the drive mechanism of FIG. 1A in an open state inwhich the pumping mechanism can be place in operative connectiontherewith.

FIG. 2B illustrates the drive mechanism of FIG. 1A in a closed state.

FIG. 3 illustrates another embodiment of a fluid delivery system of thepresent invention in which a pumping mechanism is connectable to a fluidcontainer.

FIG. 4A illustrates another embodiment of a fluid delivery system of thepresent invention in which the pumping mechanism thereof includes aplurality of pressurizing chambers in which pistons are slidablypositioned.

FIG. 4B illustrates a schematic drawing of the fluid delivery system ofFIG. 4A showing a multi-patient disposable portion and a per-patientdisposable portion.

FIG. 5 illustrates a sterile packaged kit including the fluid deliverysystem of FIG. 4A.

FIG. 6 illustrates a top, cutaway view of the pumping mechanism of thefluid delivery of FIG. 4A.

FIG. 7 illustrates an alternative embodiment of a fluid delivery systemof the present invention, which operates similarly to the fluid deliverysystem of FIG. 4A, but in which the pumping mechanism is connected tothe fluid container or source directly without intervening tubing.

FIG. 8 illustrates the use of a plurality of fluid delivery systems ofthe present invention to inject multiple fluids into a patient.

FIG. 9 illustrates another embodiment of a fluid delivery system of thepresent invention in which multiple fluid containers or sources are influid connection with a single pumping mechanism to inject multiplefluids into a patient.

DETAILED DESCRIPTION OF THE INVENTION

In general, the present invention provides fluid delivery systems thatcan be used to inject one or more fluids into one or more patients.FIGS. 1A through 1D illustrate an embodiment of a fluid delivery system10 of the present invention in which a fluid container 100 is inoperative connection with a continuous pumping mechanism 200 includingmultiple pressurizing chambers. In the embodiment of FIGS. 1A through1C, pumping mechanism 200 includes three pressurizing chambers 210 a,210 b and 210 c. System 10 further includes an actuator or drivemechanism 300, which operates in connection with pumping mechanism 200to pump fluid from within fluid container 100.

In one embodiment, each of pressurizing chambers 210 a, 210 b and 210 cis formed from a flexible, resilient material such as a resilientpolymeric material (for example, silicone polymer materials, urethanepolymer materials and vinyl polymer materials). Drive mechanism 300includes drive members 310 a, 310 b and 310 c, which cooperate withchambers 210 a, 210 b and 210 c, respectively, to pressurize fluidwithin chambers 210 a, 210 b and 210 c. In that regard, drive members310 a, 310 b and 310 c operate in a reciprocating manner (similar to apiston) to compress (see FIG. 1D) chambers 210 a, 210 b and 210 c in analternating, timed manner or sequence to provide continuous flow from acommon outlet 220, which is in fluid connection with each of chambers210 a, 210 b and 210 c. Preferably, the compression of the pressurizingchambers is timed to reduce pulsatile nature of the resultant flow.Control of pumping mechanisms including multiple pressurizing chambersto reduce pulsatile flow is further discussed below in connection withthe fluid delivery system of FIGS. 4A through 5.

Drive mechanism 300 includes a closure 320 which is illustrated in anopen state in FIGS. 1A and 1B. During use, an operator positionschambers 210 a, 210 b and 210 c in operative connection with drivemechanism 300 so that each of chambers 210 a, 210 b and 210 c arepositioned adjacent drive members 310 a, 310 b and 310 c, respectively,as illustrated, for example, in FIG. 1B. The operator then rotatesclosure 320 to a closed state as illustrated in FIG. 1C. A latch or lockmechanism 330 cooperates with closure 320 to maintain closure 320 in aclosed state. Drive mechanism 300 is also illustrated in an open stateand a closed state (absent pumping mechanism 200) in FIGS. 2A and 2B,respectively.

In the embodiment of FIGS. 1A through 1D, container 100 is permanentlyor unremovably in fluid connection with pumping mechanism 200 viaconnective tubing segments 150 a-c. As used herein, the terms“permanently” or “unremovably” do not mean that container 100 andpumping mechanism 200 must be in fluid connection under all conditions,but that container 100 and pumping mechanism 200 will remain in fluidconnection under all normal condition (including, those conditionsexperienced during transporting and operating the fluid deliverysystem). One can, for example, cut tubing segments 150 a-c or apply avery large force to tubing segments 150 a-c to break the fluidconnection between container 100 and pumping mechanism 200. However,such operations would not typically occur, even accidentally, duringnormal transport or operation. Moreover, such an operation would leavefluid delivery system 10 in a damaged state recognizable by an operator,who could discard the damaged fluid delivery system. Thus, under normaloperation, an operator is not required to make any fluid pathconnections between container 100 and pumping mechanism 200 and cannotbreak any fluid connection between container 100 and pumping mechanism200. Permanent connection can, for example, be effected by forming thepumping mechanism of the present invention integrally with thecontainers of the present invention or through the use of nonremovableconnections of flow path element (using, for example, plastic welds,adhesives etc. as known in the art).

Container 100 can include a port 105 through which, for example,additional or other fluids can be injected into container 100. In manycases, however, it may be undesirable to allow fluid to be transferredinto container 100. Introduction of fluid into container 100 afterinitial distribution thereof can, for example, introduce contaminant(s),introduce air, or result in injection of an incorrect or undesirablefluid (or fluid concentration). Moreover, it can be desirable to preventliquids from entering container 100 to, for example, ensure that a knowninjection fluid composition is injected and to prevent “refilling”and/or reuse of container 100 (which can, for example, increase the riskof contamination). Container 100 can also include one or more outletports 170 through which fluid can pass out of container 100 to adestination other than pumping mechanism 200. Such ports 170 can includea one-way valve 175 to prevent fluid from passing therethrough intocontainer 100.

In the embodiment of FIGS. 1A through 1D, one-way valves (for example,duck-billed check valves) 212 a, 212 b and 212 c are placed in fluidconnection with pressurizing chambers 210 a, 210 b and 210 c,respectively, to allow fluid to enter pressurizing chambers 210 a, 210 band 210 c from container 100, but to prevent fluid from flowing frompressurizing chambers 210 a, 210 b and 210 c into container 100.Likewise, one-way valves (for example, duck-billed check valves) 214 a,214 b and 214 c are placed in fluid connection with pressurizingchambers 210 a, 210 b and 210 c, respectively, to allow fluid to flowfrom pressurizing chambers 210 a, 210 b and 210 c to outlet 220, but toprevent fluid from flowing from outlet 220 into pressurizing chambers210 a, 210 b and 210 c. The one-way valve configuration described abovefacilitates pressurization of the fluid by pumping mechanism 200 andassists in preventing any bloodborne contaminants from one or morepatients from entering pressurizing chamber 220. Other check valves canalso be provided in fluid connection with outlet 220 to assist inpreventing cross-contamination in cases that fluid delivery system isused in connection with multiple patients.

FIG. 1E illustrates an alternative embodiment of a pumping mechanism200′ similar, in many respects, in design and operation to pumpingmechanism 200. Components of pumping mechanism 200′ are numberedsimilarly to like components of pumping mechanism 200 with the additionof the designation “′”. In the case of, pumping mechanism 200′,pressurizing chambers 210 a′, 210 b′ and 210 c′ are in fluid connectionwith a manifold 205′ that is in permanent or non-removable fluidconnection with container 100′ via a single tubing segment 150′.

FIG. 3 illustrates an alternative embodiment of a pumping mechanism 200″similar in design and operation to pumping mechanism 200. Components ofpumping mechanism 200″ are numbered similarly to like components ofpumping mechanism 200 with the addition of the designation “″”. Unlikepumping mechanism 200, however, pumping mechanism 200″ is disconnectableor removable from container 100″. In the embodiment of FIG. 3, pumpingmechanism 200″ can be placed in fluid connection with container 100″ viacooperation of a connector 250″ in the form of a piercing member orspike, which cooperates with a cooperating connector in the form of apierceable septum 150″ on container 100″ as known in the art.

FIGS. 4A through 5 illustrates another embodiment of a fluid deliverysystem 300 of the present invention. Fluid delivery system 300 includesa fluid container 400 in generally permanent or non-removable fluidconnection with a pumping mechanism 500 via tubing 450. Pumpingmechanism 500 operates essentially as set forth in U.S. Pat. Nos.5,916,197 and 6,197,000, assigned to the assignee of the presentinvention, the disclosure of which is incorporated herein by reference.

Pumping mechanism 500 includes a plurality of pressurizing chambers. Inthe embodiment of FIGS. 4A through 5, pumping mechanism includes threepressurizing chambers 510 a, 510 b and 510 c. Each of pressurizingchambers 510 a, 510 b and 510 c includes a piston 512 a, 512 b and 512c, respectively, slidably disposed therein. Pistons 512 a, 512 b and 512c are in operative connection with connectors 514 a, 514 b and 514 cwhich cooperate with connectors 614 a, 614 b and 614 c, respectively, ofa drive mechanism 600. Connectors 614 a, 614 b and 614 c are inoperative connection with drive members 610 a, 610 b and 610 c,respectively, of drive mechanism 600. As described in U.S. Pat. Nos.5,916,197 and 6,197,000, drive members 610 a, 610 b and 610 c can, forexample, be actuated in a timed manner or sequence to reduce anypulsatile nature of the flow of fluid exiting pumping mechanism 500.Each drive member 610 a, 610 b and 610 c can, for example, attached to acam shaft 620 via bearing assemblies as described in U.S. Pat. Nos.5,916,197 and 6,197,000. Cam shaft 620 is in operative connection with amotor 630. Motor 630 or pumping mechanism 500 can, for example, includea mechanism 633 (see FIG. 4B) such as a mechanical or electrical stopmechanism in operative connection therewith to prevent operation ofpumping mechanism 500 in a reverse direction (or a direction that wouldresult in fluid flow into or toward container 400.

As also disclosed in U.S. Pat. Nos. 5,916,197 and 6,197,000, eachpressurizing chamber 510 a, 510 b and 510 c includes an inlet port 522a, 522 b and 522 c and an outlet port 532 a, 532 b and 532 c,respectively (see FIGS. 4B and 6). Inlet ports 522 a, 522 b and 522 cand outlet ports 532 a, 532 b and 532 c are, for example, provided withone-way valves 540 to ensure the desired direction of flow ismaintained. Inlet port 522 a, 522 b and 522 c are in fluid connectionwith a common inlet channel 520 (which is in fluid connection withcontainer 400 via tubing 450), while outlet port 532 a, 532 b and 532 care in fluid connection with a common outlet channel 530. Inlet channel520 and outlet channel 530 are part of a head 505 (see, for example,FIG. 4A), which can, for example, be fabricated from an integral pieceof polymeric material. One-way valves 540 used in connection with theinlet ports 522 a, 522 b and 522 c and outlet ports 532 a, 532 b and 532c of pressurizing chambers 510 a, 510 b and 510 c can, for example,include flexible disks that act as valves to allow unidirectional flowinto or out of each pressurizing chamber. Flexible check valves 540 can,for example, be made of rubber or a lightweight polymer. Such one-wayvalves operate to prevent flow from pumping mechanism 500 towardcontainer 400 via tubing 450.

Fluid delivery system 300 is placed in fluid connection with a patient(not shown) via a per-patient disposable tubing or administration set700. Tubing set 700 can, for example, include at least one connector 720on a first end thereof that cooperates with a connector 560 on an outletof pumping mechanism 500 to place tubing set 700 in removable fluidconnection with pumping mechanism 500. A second end of tubing set 700can include a connector 740 to form a connection with, for example, acatheter such as a butterfly catheter 800, which includes a cooperatingconnector 840. Connectors 560 and 720, as well as connectors 740 and 840can, for example, be cooperating Luer connectors as known in the art.

Tubing set 700 can also be connected to pumping mechanism via adisconnectable aseptic connection (that is, connector sections 560 and720 form a removable aseptic connection). For example, disconnectableaseptic connectors suitable for use in the present invention aredisclosed in U.S. Pat. Nos. 6,471,674, 6,699,219, 6,440,107 and6,096,011, and Published US Patent Application No. 2003/0014035 (Ser.No. 10/190,361), assigned to the assignee of the present invention, thedisclosures of which are incorporated herein by reference. Use of such adisconnectable aseptic connection can, for example, facilitate use offluid delivery system 300 with multiple patients. In that regard,container 400 can be provided with sufficient fluid for use withmultiple patients. In such an embodiment, a different per-patientdisposable tubing set 700 can be used in connection with each patient. Aone-way valve or check valve 710 can be placed in line near the outletof tubing set 700 to prevent flow of fluid from a patient towardconnector 720. After an injection procedure with a patient, tubing set700 is removed from connection with pumping mechanism 500. Asepticconnector 560 (for example, a swabable valve) can, for example, be wipedwith a antiseptic wipe prior to connection of a new tubing set 700 toreduce any risk of cross-contamination between patients. Subsequently, anew sterile tubing set 700 can be connected to pumping mechanism 500 viaaseptic connection 560 and another injection procedure performed with adifferent patient. Fluid delivery set 300 can, for example, bc discardedafter use with a predetermined number of patients (for example, tenpatients).

Tubing sets 700 for use in the present invention can, for example, beprovided with more than one connector 720 to enable connection of morethan one fluid delivery system 300 thereto. This can, for example,facilitate attachment of a second fluid delivery system to tubing set700 if there is insufficient fluid in the first fluid delivery system toperform a specific injection with a patient. The second connector 720(not shown, but identical to first connector 720), can include aprotective cap to maintain the sterility thereof until use there may berequired. Use of such a second connector in tubing set 700 can, forexample, prevent waste of an amount of fluid in a particular fluiddelivery system when the remaining fluid is insufficient to perform aninjection procedure.

FIG. 5 illustrates fluid delivery system 300 packaged in a sterilepackage 1000 for distribution. As illustrated, container 400 is inpermanent fluid connection with pumping mechanism 500 via tubing 450 asshipped within sterile packaging 1000. In the embodiment of FIG. 5, aplurality of sterile per-patient disposable tubing sets 700 are includein package 1000 to, for example, facilitate use of fluid delivery set300 with multiple patients as described above. One of tubing sets 700can, for example, be placed in sterile fluid connection with pumpingmechanism 500 prior to distribution in package 1000. Package 1000 canalso include a manual syringe 1100 which can, for example, be used todraw blood from a patient through a port 760 on tubing set 700 toconfirm patency of catheter 800 within a patient's vein. In that regard,if flow through tubing set 700 cannot be reversed using pumpingmechanism 500, syringe 1100 provides a simple mode of confirmingpatency. Port 760 can include a control valve 770 in fluid connectiontherewith to prevent fluid from exiting port 760 when tubing set 700 isunder fluid pressure during an injection.

In one embodiment, fluid container 400 is a flexible container similarto a flexible fluid bag as known in the medical arts. With use of aflexible fluid container it is possible to substantially or evencompletely remove air from container 400 prior to distribution of fluiddelivery system 400, thereby substantially reducing the risk ofinjecting large quantities of air into a patient. Container 400 caninclude an openable port 460 such as a tear-off or break-off port asknown in the art (available, for example, from Qosina Corp of Edgewood,N.Y.) that prevents fluid from flowing from container 400 into tubing450 (or into container 400) until an operator opens port 460. Such aport can be placed inside container 400 or exterior to container 400 andin fluid connection with tubing 450. After port 460 is placed in an openstate, an operator preferably primes tubing 450, pumping mechanism 500and tubing set 700 to remove air therefrom by displacing such air withfluid from container 400. One or more air detectors 322 can also beplaced in fluid connection with fluid delivery system 300 and or tubingset 700 to provide further assurance that air is not injected into apatient.

As further illustrated in FIG. 4A, a controller 900 can be placed inoperative communicative connection with drive mechanism 600. Examples ofcontrol of flow from multiple pharmaceutical fluid containers(including, syringes and other containers) is, for example, disclosed inU.S. Pat. No. 5,840,026, U.S. Pat. No. 6,643,537 and Published U.S.Patent Application No. 2004/0064041 (Ser. No. 10/159,592), assigned tothe assignee of the present invention, the disclosures of which areincorporated herein by reference. Pumping mechanism 500 (and/or othersystem components such as container 400) can, for example, include oneor more readable information stores or indicators 570 that can be readby, for example, controller 900 to provide information to controller 900regarding the configuration of fluid delivery system 600 (for example,fluid volume, fluid identity, concentration etc.) to facilitate controlof drive mechanism 600. As illustrated in FIG. 5, information store 570can for example be an optically readable bar code. Information store orindicator 570 can also, for example, be an RFID (radio frequencyidentification) tag as known in the art or other electrical orelectromechanical coding system as known in the art. Coding systems usedin connection with syringes that can also be used or adapted for use inconnection with the fluid delivery systems of the present invention are,for example, disclosed in U.S. Pat. No. 6,743,202 and Published U.S.Patent Application Nos. 2003/0065287 (Ser. No. 10/114,710), 2002/0128606(Ser. No. 09/765,498) and 2004/0064101 (Ser. No. 10/466,418), assignedto the assignee of the present invention, the disclosures of which areincorporated herein by reference. Tubing set 700 can likewise include aninformation store or indicator 705 to provide information on theconfiguration thereof to controller 900. Such information (for example,volume information) can, for example, be used to enable an automatedpriming function in which pumping mechanism 500 and tubing set 700 areprimed with activation of a single switch by an operator.

In addition to flow control, controller 900 can, for example, note whena fluid delivery system 300 has been attached to drive mechanism 600 andbegin countdown of a time period (for example, 24 hours) during whichthe fluid in container 400 must be injected or discarded. An alert canbe provided or flow can be prevented (by, for example, flow controller900 or other system element) after such time period. Flow Controller 900can also provide an alert as to when there is insufficient fluid withincontainer 400 to perform a specific injection procedure. At this point,a new or second fluid delivery system 300 can be placed in fluidconnection with tubing set 700 as described above to ensure thatsufficient fluid is available for the injection procedure.

A bulk fluid heating system 315 a (see, FIG. 4A) can be placed inoperative connection with container 400 to heat the fluid to atemperature (for example, body temperature) to make the injectionprocedure more comfortable for a patient. Heating the fluid can alsofacility delivery by reducing viscosity. Alternatively or additionallyan inline, real time heating system 315 b can be placed in operativeconnection with the fluid path. In the embodiment, of FIG. 4A, heatingsystem 315 b is place in operative connection with tubing 450.

FIG. 7 illustrates another embodiment of a fluid delivery system 300 ain which a pumping mechanism 500 a, which operates substantially thesame as pumping mechanism 500, is formed integrally with container 400 awithout intervening tubing. In that regard, an inlet 502 a of head 505 aof pumping mechanism 500 a is in direct fluid connection with theinterior of container 400 a. Pumping mechanism outlet 504 a can, forexample, be in fluid connection with an aseptic connector as describedabove for connection of tubing set 700 thereto. Inlet 502 a can includea break-off port as described above. Pumping mechanism 500 a operates inconnection with drive mechanism 600 via connectors 512 aa, 512 ab and512 ac, as described above in connection with pumping mechanism 500.

In many injection procedures, it is desirable to inject two or morefluids into a patient (simultaneously or sequentially). For example,saline is often used in connection with a contrast medium. Asillustrated in FIG. 8, multiple fluid delivery systems 300 b and 300 c(substantially identical to fluid delivery system 300 with likecomponents therewith numbered accordingly) can be provided to inject aplurality of fluids into a patient (for example, contrast and saline).Although two fluid delivery systems 300 b and 300 c are shown in FIG. 8,more than two such systems can be provided to inject three or morefluids into a patient during a single injection procedure. Such fluiddelivery systems can be distributed in the same or different sterilepackages as, for example, described in connection with FIG. 5. As clearto one skilled in the art, controller 900 can readily be used inconnection with multiple fluid delivery systems of the presentinvention. In the embodiment, of FIG. 8, each of fluid delivery systems300 b and 300 c are in fluid connection with a common mixing element orchamber 360, which can be place in fluid connection with a per-patientdisposable tubing set as described above. Controller 900 can, forexample, control (and vary) flow from each of fluid delivery systems 300b and 300 c to control (and vary) total flow rate and relativeconcentration of each fluid during the course of an injection procedure.

In the embodiment of FIG. 9, a fluid delivery system 1300 is illustratedwhich includes a plurality of (that is, two or more) containers 1400 aand 1400 b which are connected to a single pumping mechanism 1500 via amultiport control valve 1580. Control valve 1580 and drive mechanism1600 can, for example, be controlled via a controller 1900 to inject adesired amount of either of both of the fluids enclosed in containers1400 a and 1400 b.

In the systems of the present invention, total fluid injection rate canbe maintained constant or varied in virtually any manner while flow rateof the component fluids can be varied independently. An injectionprotocol including the parameters for the injection can be input intocontroller 900 based upon, for example, patient specific parameters.Moreover, feedback of one or more measured variables (for example,patient variables, measured contrast enhancement, etc.) can be used toalter the injection protocol in real time.

Although the present invention has been described in detail inconnection with the above embodiments and/or examples, it should beunderstood that such detail is illustrative and not restrictive, andthat those skilled in the art can make variations without departing fromthe invention. The scope of the invention is indicated by the followingclaims rather than by the foregoing description. All changes andvariations that come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

1. A fluid delivery system comprising: a fluid container; a pumpingmechanism comprising two or more pressurizing chambers in fluidconnection with the fluid container, each of the two or morepressurizing chambers being formed from a flexible, resilient materialthat is adapted to be compressed to pressurize fluid therewithin; adrive mechanism in operative connection with the two or morepressurizing chambers of the pumping mechanism to pump fluid from thefluid container; and an outlet in fluid connection with the two or morepressurizing chambers.
 2. The fluid delivery system of claim 1, furthercomprising two or more tubing segments in fluid connection between thetwo or more pressurizing chambers and the fluid container to place thetwo or more pressurizing chambers in fluid connection with the fluidcontainer.
 3. The fluid delivery system of claim 1, further comprising acheck valve in fluid connection with the outlet to prevent contaminantsfrom entering into the pumping mechanism.
 4. The fluid delivery systemof claim 1, further comprising two or more first valves disposed in thetwo or more pressurizing chambers between the fluid container and theoutlet, the two or more first valves adapted to allow flow from thefluid container into the two or more pressurizing chambers but toprevent flow from the two or more pressurizing chambers into the fluidcontainer.
 5. The fluid delivery system of claim 4, further comprisingtwo or more second valves disposed in the two or more pressurizingchambers between the two or more first valves and the outlet, the two ormore second valves adapted to allow flow from the two or morepressurizing chambers into the outlet but to prevent flow from theoutlet into the two or more pressurizing chambers.
 6. The fluid deliverysystem of claim 1, further comprising a manifold in fluid connectionwith the two or more pressurizing chambers and a tubing segment in fluidconnection with the fluid container and the manifold to place the two ormore pressurizing chambers in fluid connection with the fluid container.7. The fluid delivery system of claim 6 wherein the tubing segmentcomprises a connector that cooperates with a cooperating connector onthe fluid container to place the two or more pressurizing chambers influid connection with the fluid container.
 8. The fluid delivery systemof claim 7 wherein the connector on the tubing segment is a piercingmember and the cooperating connector on the fluid container is apierceable septum.
 9. The fluid delivery system of claim 1 wherein thetwo or more pressurizing chambers comprises three pressurizing chambers.10. The fluid delivery system of claim 1 wherein the fluid containercomprises an inlet port through which additional fluid or another fluidcan be delivered into the fluid container.
 11. The fluid delivery systemof claim 1 wherein the fluid container comprises one or more outletports through which fluid can be delivered to a destination other thanthe pumping mechanism.
 12. The fluid delivery system of claim 1 whereinthe pumping mechanism is permanently in fluid connection with the fluidcontainer.
 13. The fluid delivery system of claim 1 wherein the drivemechanism comprises two or more drive members that cooperate with thetwo or more pressurizing chambers, respectively, to pressurize fluidwithin the two or more pressurizing chambers.
 14. The fluid deliverysystem of claim 13 wherein the drive members are driven in areciprocating manner to compress the respective pressurizing chambers inan alternating, timed sequence to provide substantially continuous fluidflow from the outlet.
 15. The fluid delivery system of claim 13 whereinthe drive mechanism further comprises a closure that is adapted to bemoved between an open position and a closed position of the drivemechanism.
 16. The fluid delivery device of claim 1 wherein the flexiblematerial of the two or more pressurizing chambers is suitably resilientsuch that recovery of the flexible material creates a pressuredifference between the two or more pressurizing chambers and the fluidcontainer suitable to draw fluid from the fluid container into the twoor more pressurizing chambers.
 17. The fluid delivery system of claim 1,further comprising at least one tubing set that is adapted to beconnected to the outlet.
 18. The fluid delivery system of claim 17wherein the at least one tubing set comprises a plurality of disposabletubing sets that are connected to the outlet sequentially to allowinjection of fluid from the fluid container into multiple patients. 19.The fluid delivery system of claim 18 wherein the outlet comprises aswabable connector that is adapted to be cleaned after a disposabletubing set has been removed therefore and prior to connection of anotherdisposable tubing set thereto.
 20. A fluid delivery system comprising:at least one inlet connectable to a fluid container; at least tworesilient pressurizing chambers in fluid connection with the at leastone inlet, each of the at least two pressurizing chambers being formedfrom a flexible material that can be compressed to pressurize fluidwithin the at least two pressurizing chambers; a common outlet in fluidconnection with the at least two pressurizing chambers; at least twoinlet valves, each in fluid connection with a respective one of the atleast two pressurizing chambers between the fluid container and thecommon outlet, the at least two inlet valves being operable to allowfluid to enter the at least two pressurizing chambers from the fluidcontainer but to prevent fluid from flowing from the at least twopressurizing chambers into the fluid container; and at least two outletvalves, each in fluid connection with a respective one of the at leasttwo pressurizing chambers between the at least two pressurizing chambersand the common outlet, the at least two outlet valves being operable toallow fluid to enter the common outlet from the at least twopressurizing chambers but to prevent fluid from flowing from the commonoutlet into the at least two pressurizing chambers.